Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.

NCT07734220 | Completed FDA Device

• 1 other identifier: MED-2025-DIV75-002
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to compare heel off-loading capabilities of two products

Conditions

Pressure Injuries

Keywords

pressure mapping

Outcome Measures

Primary Outcomes (1)

• To evaluate heel offloading capabilities of two heel protection boot devices

  The primary endpoint will be the percentage change in peak and average pressures in the lower extremity (measuring heel, calf and combination)

  3-6 months

Interventions

HeelMedix Basic & EHOB Waffle DEVICE

Participants will then have a baseline pressure mapping measurement taken, where they will be instructed to outstretch their right leg in front of them onto the BPMS pressure mat. The baseline peak and average pressures of the lower extremity in the heel, calf and combination of heel and calf as shown on the TekScan software connected to the mat will be recorded on the designated CRF. Pressure minimum and standard deviation will also be recorded. Once baseline measurements are complete, the first of two study devices will be applied to the participant, and they will place their leg back on the pressure mat in the same manner as the baseline measurement. Peak and average pressures of the lower extremity while wearing the first study device, in the heel, calf and combination of heel and calf as shown on the TekScan software connected to the mat will be recorded on the designated CRF. Pressure minimum and standard deviation will also be recorded. Steps will be repeated for 2nd device.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total number of participants, N=25

You may qualify if:

• Individual is ≥ 22 years old
• Self-reported to be in healthy condition.
• Able to remain seated on a hard surface such as the floor and wear a heel protectant boot for at least thirty minutes.
• Able to understand and willing to carry out instructions for this study.
• Has a calf circumference of 11-19 inches

You may not qualify if:

• Self-reported to have pre-existing pathology associated with lower extremities
• Individual has a calf circumference of less than 11 inches or greater than 19 inches
• Individual is employed in a division of Medline Industries, LP under which the study product(s) are developed
• Individual is sensitive to the materials of the study product(s)
• Medline Contractors

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Medline Industries, LP

Northfield, Illinois, 60093, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gregory J Gomez, RN BSN MPH

  Medline Industries, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: July 8, 2026
• Primary Completion: July 22, 2026
• Study Completion: July 22, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)